Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC

Active:	No
Cancer Type:	Lung Cancer	NCT ID:	NCT03041311
Trial Phases:	Phase II	Protocol IDs:	G1T28-05 (primary) NCT03041311 2017-000358-20
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	G1 Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03041311

Summary

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in
preserving the bone marrow and the immune system, and enhancing antitumor efficacy when
administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line
treatment for patients with newly diagnosed extensive-stage SCLC.

The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100
patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.

Objectives

The posted results represent the final results from Study G1T28-05, a Phase 2 study of
carboplatin, etoposide, and atezolizumab with or without trilaciclib (G1T28) in patients
with untreated extensive-stage small cell lung cancer (SCLC).

The final myelopreservation efficacy results are from database lock 1 (data cut-off [DCO]
17 Aug 2018). The final anti-tumor efficacy data (BOR, DOR, PFS) are from a second
database lock 2 (DCO 28 June 2019) that occurred to support the trilaciclib New Drug
Application (NDA). Final overall survival and safety data are reported from the final
study database lock (DCO 11 Dec 2020, last patient last visit date of 29 October 2020).

Please note the last patient last visit date description above which is recorded as the
study completion date. Following the last patient last visit, the final database lock
occurred a few weeks later which accounts for the discrepancy between the study
completion date and the reported assessment time frames.

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